Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018
This bill amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must publish annual summaries on any use of the drug in accordance with these provisions.
The bill limits the liability of a sponsor, manufacturer, licensed physician, clinical investigator, or hospital that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5247 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
H. R. 5247
To authorize the use of eligible investigational drugs by eligible
patients who have been diagnosed with a stage of a disease or condition
in which there is reasonable likelihood that death will occur within a
matter of months, or with another eligible illness, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 13, 2018
Mr. Fitzpatrick (for himself, Mr. Biggs, Mr. Griffith, Mr. Barr, Mr.
Barton, Mrs. Blackburn, Mr. Buchanan, Mr. Carter of Georgia, Mr.
Burgess, Mrs. Comstock, Mr. Cramer, Mr. Culberson, Mrs. Black, Mr.
Dunn, Mr. Faso, Mr. Hill, Mr. Gallagher, Mrs. Handel, Mrs. Hartzler,
Mr. Issa, Mr. Lewis of Minnesota, Mr. Buck, Mr. Lamborn, Mr. Marshall,
Mr. Meadows, Mr. Messer, Mr. Brooks of Alabama, Mr. Gosar, Mr. Rothfus,
Mr. Schweikert, Ms. Sinema, Mr. King of Iowa, Mr. Yoho, Mr. Weber of
Texas, Mr. Collins of New York, Mr. Yoder, Mr. Harper, Mr. Lance, Mr.
Allen, Mr. Duncan of South Carolina, and Ms. Herrera Beutler)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To authorize the use of eligible investigational drugs by eligible
patients who have been diagnosed with a stage of a disease or condition
in which there is reasonable likelihood that death will occur within a
matter of months, or with another eligible illness, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Trickett Wendler, Frank Mongiello,
Jordan McLinn, and Matthew Bellina Right to Try Act of 2018''.
SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY PATIENTS DIAGNOSED
WITH A TERMINAL ILLNESS.
(a) In General.--Subchapter E of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by
inserting after section 561A (21 U.S.C. 360bbb-0) the following:
``SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE PATIENTS.
``(a) Definitions.--For purposes of this section:
``(1) The term `eligible patient' means a patient--
``(A) who has been diagnosed with an eligible
illness;
``(B) who has exhausted approved treatment options
and is not eligible to participate in (for a reason
such as the patient not meeting inclusion criteria) a
clinical trial designed to evaluate an investigational
drug for the treatment of such eligible illness with
which the patient has been diagnosed, including one
involving the eligible investigational drug, or for
whom participation in such a clinical trial is not
feasible (for a reason such as a lack of geographic
proximity to the clinical trial), as certified by a
physician, who--
``(i) is in good standing with the
physician's licensing organization or board;
and
``(ii) will not be compensated for so
certifying; and
``(C) who has provided to the treating physician
written informed consent, as described in part 50 of
title 21, Code of Federal Regulations (or any successor
regulations), regarding the eligible investigational
drug, or, as applicable, on whose behalf a legally
authorized representative of the patient has provided
such consent.
``(2) The term `eligible investigational drug' means an
investigational drug (as such term is used in section 561)--
``(A) for which a phase 1 clinical trial has been
completed;
``(B) that has not been approved or licensed for
any use under section 505 of this Act or section 351 of
the Public Health Service Act;
``(C)(i) for which an application has been filed
under section 505(b) of this Act or section 351(a) of
the Public Health Service Act, as applicable, that is
active; or
``(ii) that is under investigation in a clinical
trial that--
``(I) is intended to form the primary basis
of a claim of effectiveness in support of
approval or licensure under section 505 of this
Act or section 351 of the Public Health Service
Act; and
``(II) is the subject of an active
investigational new drug application under
section 505(i) of this Act or section 351(a)(3)
of the Public Health Service Act, as
applicable; and
``(D) the active development or production of
which--
``(i) is ongoing;
``(ii) has not been discontinued by the
manufacturer; and
``(iii) is not the subject of a clinical
hold under the regulations implementing section
505(i) or section 351(a)(3) of the Public
Health Service Act, as applicable.
``(3) The term `phase 1 trial' means a phase 1 clinical
investigation of a drug as described in section 312.21 of title
21, Code of Federal Regulations (or any successor regulations).
``(4) The term `eligible illness' means--
``(A) a stage of a disease or condition in which
there is reasonable likelihood that death will occur
within a matter of months; or
``(B) a disease or condition that would result in
significant irreversible morbidity that is likely to
lead to severely premature death.
``(b) Alternative Pathway for Eligible Patients With a Terminal
Illness.--
``(1) In general.--Eligible investigational drugs provided
to eligible patients in compliance with this section are exempt
from sections 502(f), 503(b)(4), and subsections (a) and (i) of
section 505 of this Act, and section 351(a) of the Public
Health Service Act so long as the conditions specified in
paragraphs (2), (3), and (4) are met with respect to the
provision of such investigational drugs.
``(2) Compliance with certain regulations.--The conditions
specified in this paragraph, with respect to an eligible
investigational drug referred to in paragraph (1), are that--
``(A) the eligible investigational drug is labeled
in accordance with section 312.6 of title 21, Code of
Federal Regulations (or any successor regulations); and
``(B) the provision of such eligible
investigational drug occurs in compliance with the
applicable requirements set forth in sections 312.7 and
312.8(d)(1) of title 21, Code of Federal Regulations
(or any successor regulations) that apply to
investigational drugs, subject to paragraph (5).
``(3) Notification.--The condition specified in this
paragraph, with respect to an eligible investigational drug
referred to in paragraph (1), is that the sponsor of such
eligible investigational drug notifies the Secretary of the
provision of such eligible investigational drug for use by an
eligible patient pursuant to this section. Such notification
shall be submitted within 7 business days of the provision of
such eligible investigational drug as correspondence to the
investigational new drug application described in subsection
(a)(2).
``(4) Adverse event reporting.--The condition specified in
this paragraph, with respect to an eligible investigational
drug referred to in paragraph (1), is that the sponsor or
manufacturer of such eligible investigational drug has
required, as a condition of providing the drug to a physician
for use by an eligible patient pursuant to this section, that
such physician will immediately report to such sponsor or
manufacturer any serious adverse events, as such term is
defined in section 312.32 of title 21, Code of Federal
Regulations (or any successor regulations), associated with the
use of the eligible investigational drug by the eligible
patient.
``(5) Application.--For purposes of this section, the
requirements set forth in sections 312.7 and 312.8(d)(1) of
title 21 of the Code of Federal Regulations (or any successor
regulations) are deemed to apply to any person who
manufactures, distributes, prescribes, dispenses, introduces or
delivers for introduction into interstate commerce, or provides
to an eligible patient an eligible investigational drug
pursuant to this section.
``(c) Use of Clinical Outcomes.--
``(1) In general.--Notwithstanding any other provision of
this Act, the Public Health Service Act, or any other provision
of Federal law, the Secretary may not use a clinical outcome
associated with the use of an eligible investigational drug
pursuant to this section to delay or adversely affect the
review or approval of such drug under section 505 of this Act
or section 351 of the Public Health Service Act unless--
``(A) the Secretary makes a determination, in
accordance with paragraph (2), that use of such
clinical outcome is critical to determining the safety
of the eligible investigational drug; or
``(B) the sponsor requests use of such outcomes.
``(2) Limitation.--If the Secretary makes a determination
under paragraph (1)(A), the Secretary shall provide written
notice of such determination to the sponsor, including a public
health justification for such determination, and such notice
shall be made part of the administrative record. Such
determination shall not be delegated below the director of the
agency center that is charged with the premarket review of the
eligible investigational drug.
``(d) Reporting.--The manufacturer or sponsor of an eligible
investigational drug that provides an eligible investigational drug
pursuant to this section shall post on the same publicly available
internet website used by the manufacturer for purposes of section
561A(b) an annual summary of any provision by the manufacturer or
sponsor of an eligible investigational drug under this section. The
summary shall include the number of requests received, the number of
requests granted, the number of patients treated, the therapeutic area
of the drug made available, and any known or suspected serious adverse
events, as such term is defined in section 312.32 of title 21, Code of
Federal Regulations (or any successor regulations), associated with the
use of the eligible investigational drug.
``(e) Rule of Construction.--Nothing in this section shall be
construed as limiting the authority of the Secretary to require
manufacturers or sponsors of investigational drugs to review and report
information relevant to the safety of such investigational drug
obtained or otherwise received by the sponsor pursuant to part 312 of
title 21, Code of Federal Regulations (or successor regulations).''.
(b) No Liability.--Section 561B of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), is amended by adding at the
end the following:
``(f) Liability.--
``(1) Alleged acts or omissions.--
``(A) Manufacturer or sponsor.--No manufacturer or
sponsor (or their agent or representative) of an
investigational drug shall be liable for any alleged
act or omission related to the provision of such drug
to a single patient or small group of patients for
treatment use in accordance with subsection (b) or (c)
of section 561 or the provision of an eligible
investigational drug to an eligible patient in
accordance with this section, including, with respect
to the provision of an investigational drug under
section 561 or an eligible investigational drug under
this section, the reporting of safety information, from
clinical trials or any other source, as required by
section 312.32 of title 21, Code of Federal Regulations
(or any successor regulations).
``(B) Physician, clinical investigator, or
hospital.--
``(i) No licensed physician, clinical
investigator, or hospital shall be liable for
any alleged act or omission related to the
provision of an investigational drug to a
single patient or small group of patients for
treatment use in accordance with subsection (b)
or (c) of section 561, as described in clause
(ii), or the provision of an eligible
investigational drug to an eligible patient in
accordance with this section, unless such act
or omission constitutes on the part of such
physician, clinical investigator, or hospital
with respect to such investigational drug or
eligible investigational drug--
``(I) willful or criminal
misconduct;
``(II) reckless misconduct;
``(III) gross negligence relative
to the applicable standard of care and
practice with respect to the
administration or dispensing of such
investigational drug; or
``(IV) an intentional tort under
applicable State law.
``(ii) The requirements described in this
clause are the requirements under subsection
(b) or (c) of section 561, including--
``(I) the reporting of safety
information, from clinical trials or
any other source, as required by
section 312.32 of title 21, Code of
Federal Regulations (or any successor
regulations);
``(II) ensuring that the informed
consent requirements of part 50 of
title 21, Code of the Federal
Regulations (or any successor
regulations) are met; and
``(III) ensuring that review by an
institutional review board is obtained
in a manner consistent with the
requirements of part 56 of title 21,
Code of the Federal Regulations (or any
successor regulations).
``(2) Determination not to provide drug.--No manufacturer,
sponsor, licensed physician, clinical investigator, or hospital
shall be liable for determining not to provide access to an
investigational drug under this section or for discontinuing
any such access that it initially determined to provide.
``(3) Limitation.--
``(A) In general.--Except as set forth in
paragraphs (1) and (2), nothing in this section shall
be construed to modify or otherwise affect the right of
any person to bring a private action against a
manufacturer or sponsor (or their agent or
representative), physician, clinical investigator,
hospital, prescriber, dispenser, or other entity under
any State or Federal product liability, tort, consumer
protection, or warranty law.
``(B) Federal government.--Nothing in this section
shall be construed to modify or otherwise affect the
authority of the Federal Government to bring suit under
any Federal law.''.
<all>
On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 259 - 140 (Roll no. 102).
Roll Call #102 (House)Referred to the Subcommittee on Health.
Rules Committee Resolution H. Res. 787 Reported to House. The resolution provides for one hour of debate on each bill. The resolution makes in order only the further amendment to H.R. 4566 printed in the report. No further amendments on either bill are made in order. Section 3 of the resolution makes it in order to consider any resolution reported from the Rules Committee on the day it is reported through the legislative day of March 23, 2018. Section 4 grants suspension authority on the legislative days of March 22, 2018 and March 23, 2018. Section 5 of the resolution amends section 3(a) of H. Res. 5.
Rule H. Res. 787 passed House.
Considered under the provisions of rule H. Res. 787. (consideration: CR H1738-1748)
The resolution provides for one hour of debate on each bill. The resolution makes in order only the further amendment to H.R. 4566 printed in the report. No further amendments on either bill are made in order. Section 3 of the resolution makes it in order to consider any resolution reported from the Rules Committee on the day it is reported through the legislative day of March 23, 2018. Section 4 grants suspension authority on the legislative days of March 22, 2018 and March 23, 2018. Section 5 of the resolution amends section 3(a) of H. Res. 5.
DEBATE - The House proceeded with one hour of debate on H.R. 5247.
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The previous question was ordered pursuant to the rule.
Mr. Pallone moved to recommit with instructions to the Committee on Energy and Commerce. (text: CR H1746-1747)
DEBATE - The House proceeded with 10 minutes of debate on the Pallone motion to recommit with instructions. The instructions contained in the motion seek to report the same back to the House forthwith with an amendment to require the Food and Drug Administration (FDA) to issue guidance describing how the agency will use expanded access outcomes when considering and evaluating investigational products for full approval. Additionally, the motion seeks to provide liability protection to manufacturers, physicians, and hospitals offering a product under expanded access, as long as the entity is in compliance with current federal law, and it also increases transparency in the FDAs expanded access program.
The previous question on the motion to recommit with instructions was ordered without objection.
POSTPONED PROCEEDINGS - At the conclusion of debate on the Pallone motion to recommit with instructions, the Chair put the question on the motion and by voice vote announced that the ayes had prevailed. Mr. Pallone demanded the yeas and nays, and the Chair postponed further proceedings on the motion to recommit until later in the legislative day.
Considered as unfinished business. (consideration: CR H1748-1750)
On motion to recommit with instructions Failed by the Yeas and Nays: 182 - 233 (Roll no. 120).
Roll Call #120 (House)Passed/agreed to in House: On passage Passed by recorded vote: 267 - 149 (Roll no. 121).(text: CR H1738-1739)
Roll Call #121 (House)On passage Passed by recorded vote: 267 - 149 (Roll no. 121). (text: CR H1738-1739)
Roll Call #121 (House)Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.
Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 367.